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510(k) K130400

MERETEC CS, CORTICAL SCREWS by Merete Medical GmbH — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2013
Date Received
February 19, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

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  • K141377 — BIOBALL DELTA CERAMIC HEADS, MULTICUP PE INLAY STANDARD (November 21, 2014)
  • K140069 — LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3. (April 7, 2014)
  • K132226 — METAFIX BLP PLATE, SIZE 31, LEFT, METAFIX BLP PLATE, SIZE 31,RIGHT (August 9, 2013)
  • K123619 — INTRABLOCK BIOBALL HIP SYSTEM (IBS) (May 24, 2013)
  • K120787 — MERETE LOCKING BONE PLATE SYSTEM III (November 27, 2012)
  • K120978 — OSTEOBRIDGE IKA KNEE ARTHODESIS NAIL WITH COLLAR (May 2, 2012)

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